MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT BALLOON; CATHETER, PERCUTANEOUS

Model Number	REL46
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A reliant balloon was used in a patient for the endovascular treatment of an aortic aneurysm.It was reported that the reliant balloon would not fit though a 12 fr sheath.The physician felt something ¿pop¿ in the balloon and was uncomfortable continuing to use it.Another reliant balloon was opened and fit into the sheath, this resolved the event.The physician stated that the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary the cause of the insertion difficulty and audible ¿pop¿ could not be conclusively determined as the event occurred in-vivo and could not be replicated during analysis.The competitive sheath was not returned with the reliant balloon, so the root cause of the event could not be determined; however, the competitive sheath may have contributed to the event.The reliant balloon was unremarkable and was within manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIANT BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6783877
• Report Number: 2953200-2017-01254
• Device Sequence Number: 16521098
• Product Code: DQY
• UDI-Device Identifier: 00643169707641
• UDI-Public: 00643169707641
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Device Lot Number: 0008607169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR